PT Kalbe Farma Tbk (via Public) / Kalbe Gets Phase-2 Clinica

PT Kalbe Farma Tbk (via Public) / Kalbe Gets Phase-2 Clinical Trial Approval on COVID-19 Drug


Kalbe Gets Phase-2 Clinical Trial Approval on COVID-19 Drug - GX17
Kalbe Gets Phase-2 Clinical Trial Approval on COVID-19 Drug - GX17
Jakarta, 30 December 2020 - PT Kalbe Farma Tbk (Kalbe) through its subsidiary PT Kalbe-Genexine Biologics (KGBio) today has received approval for a clinical trial (PPUK) from the Food and Drug Administration of the Republic of Indonesia (BPOM) to carry out Phase 2 clinical trials of the drug GX-17, which is an immunotherapeutic drug that will be developed as a treatment for COVID-19 patients. BPOM has issued approval to KGBio to conduct a phase-2 clinical trial based on safety and effectiveness data from a previous study conducted by Genexine with IMAB in South Korea. GX-17 is the only long-acting interleukin-7 drug under development in the world that can increase the absolute lymphocyte count. This increase in the number of lymphocytes by GX-17 can prevent the worsening of the condition of mild or asymptomatic COVID-19 patients, especially in vulnerable populations such as the elderly by activating T-cells and the immune system in the early stages of COVID-19 infection.

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